Overactive Bladder (OAB)
Conditions
Keywords
Overactive Bladder, Adrenergic beta 3 Receptor Agonists, Inflammation, Biomarkers, Blood Cell Counts, Neutrophil-to-Lymphocyte Ratio, Platelet-to-Lymphocyte Ratio, Systemic Immune-Inflammation Index, NLR, PLR, SII
Brief summary
Overactive bladder (OAB) is associated with systemic chronic inflammation. Indices derived from complete blood count (such as neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammation index (SII)) have shown associations with OAB presence. However, whether baseline inflammatory status predicts response to beta-3 adrenergic agonist therapy remains untested. This prospective observational cohort study evaluates the predictive ability of baseline NLR, PLR, and SII for 3-month treatment response to mirabegron 50 mg in women with OAB.
Detailed description
BACKGROUND AND RATIONALE: Overactive bladder (OAB) is a chronic lower urinary tract condition characterized by urinary urgency, usually accompanied by frequency and nocturia, with or without urgency incontinence. Beta-3 adrenoceptor agonists such as mirabegron are an established first-line pharmacological option, yet the individual treatment response varies considerably. Emerging evidence links systemic low-grade inflammation to OAB pathophysiology. Baseline hematological indices derived from the routine complete blood count, such as the neutrophil-to-lymphocyte ratio (NLR), the platelet-to-lymphocyte ratio (PLR), and the systemic immune-inflammation index (SII), may therefore carry predictive information at no additional cost. STUDY OBJECTIVES: This prospective observational cohort study evaluates whether baseline NLR predicts the clinical response to standard mirabegron therapy (50 mg/day) at 3 months in treatment-naive women with OAB. The discriminative ability of baseline PLR and SII and the adjusted association of NLR with response are evaluated as secondary objectives. METHODS: Consecutive eligible treatment-naive women in whom mirabegron 50 mg is initiated within routine clinical care are enrolled. Baseline evaluation includes clinical assessment, a 3-day voiding diary, a validated symptom questionnaire, routine urodynamic parameters, and a standardized complete blood count. Inflammatory indices are calculated with standard formulas. Response is assessed at 3 months. Data are collected on standardized case report forms and verified against electronic medical records. STATISTICAL CONSIDERATIONS: The enrollment target is 115 patients to reach 80 evaluable patients. The discriminative ability of baseline inflammatory indices will be evaluated with ROC curve analysis; multivariable modeling will be used to assess adjusted associations. Details are prespecified in the study protocol.
Interventions
Mirabegron 50 mg orally once daily, initiated and managed by the treating physician as part of routine clinical care. The drug is not assigned by the study protocol; the study observes patients in whom this treatment has been started within standard practice.
Sponsors
Bagcilar Training and Research Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female patients aged 18 years or older * Overactive bladder symptoms for at least 3 months * Mirabegron 50 mg planned by physician decision within routine care * Ability to provide written informed consent
Exclusion criteria
* Any previous OAB-specific treatment other than behavioral therapy (oral antimuscarinic or beta-3 agonist, intravesical botulinum toxin, sacral neuromodulation, or posterior tibial nerve stimulation) * Acute infection within the last 4 weeks, including culture-confirmed urinary tract infection * Chronic inflammatory disease (rheumatologic or autoimmune disease, or inflammatory bowel disease) * Active malignancy or cancer treatment within the last 5 years * Use of systemic glucocorticoids within the last 4 weeks, or chronic NSAID or immunosuppressive use * Conditions affecting lower urinary tract function other than OAB (neurogenic bladder, urinary tract stones, history of pelvic radiotherapy or bladder surgery, pelvic organ prolapse stage 3 or higher, or stress-predominant mixed urinary incontinence) * Known diagnosis of hematologic disease, anemia (Hb\<9), or platelet disorder (PLT\<100.000 or \>600.000) * Significant renal or hepatic impairment (eGFR below 30 mL/min/1.73 m2, or Child-Pugh class B or C) * Uncontrolled hypertension (180/110 mmHg or higher) or any other contraindication to mirabegron * Pregnancy or lactation * Major surgery or trauma within the last 3 months * Cognitive or functional inability to complete the voiding diary
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Discriminative ability of baseline neutrophil-to-lymphocyte ratio for mirabegron treatment response | 3 months | Treatment response is defined as a composite of a reduction of at least 50 percent from baseline in the symptom severity score of the Overactive Bladder Questionnaire Short Form (OAB-q SF) AND a reduction of at least 2 in the mean number of daily urgency episodes on a 3-day voiding diary; both conditions are required. The OAB-q SF symptom severity score is transformed to a 0 to 100 scale, with higher scores indicating greater symptom severity; a decrease therefore represents improvement. The area under the ROC curve (AUC) of baseline neutrophil-to-lymphocyte ratio for discriminating responders from non-responders is reported with its 95 percent confidence interval. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Discriminative ability of baseline platelet-to-lymphocyte ratio for mirabegron treatment response | 3 months | The area under the ROC curve of baseline PLR for discriminating responders from non-responders (composite response definition) is reported with its 95 percent confidence interval. |
| Discriminative ability of baseline systemic immune-inflammation index for mirabegron treatment response | 3 months | The area under the ROC curve of baseline SII for discriminating responders from non-responders (composite response definition) is reported with its 95 percent confidence interval. |
| Association of baseline NLR with mirabegron treatment response adjusted for clinical covariates | 3 months | The adjusted odds ratio and 95 percent confidence interval for baseline NLR are estimated with composite treatment response as the dependent variable. |
Countries
Turkey (Türkiye)
Contacts
CONTACTÖzgür Aslan, MD
PRINCIPAL_INVESTIGATORÖzgür Aslan, MD
Bagcilar Training and Research Hospital
Outcome results
None listed